GMPs

Jan 02, 2018
Pharmaceutical Technology
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
Dec 28, 2017
By Pharmaceutical Technology Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
Dec 20, 2017
Equipment and Processing Report
Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.
Dec 18, 2017
By Pharmaceutical Technology Editors
The agency published guidance on the research and development of individualized therapies.
Dec 18, 2017
By Pharmaceutical Technology Editors
The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
Dec 14, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
Dec 12, 2017
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
Dec 07, 2017
An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.
Dec 02, 2017
Pharmaceutical Technology
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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